LumiraDx Instrument User Manual Download Page 6

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Abbreviations

CDC

Centers for Disease Control and Prevention

EHR

Electronic Health Record

HCP

Health Care Professional

ID Identification

Quality Control

RFID

Radio-Frequency Identification

United Kingdom

USB

Universal Serial Bus

WHO

World Health Organization

HIS

Hospital Information Service

LIS

Laboratory Information Service

DOB

Date of Birth

Summary of Contents for Instrument

Page 1: ...Platform User Manual...

Page 2: ......

Page 3: ...1 Platform User Manual...

Page 4: ...e Number Serial Number CE Mark The product is in compliance with all relevant European Directives and Regulations Refer to Declaration of Conformity for full details Caution Consult Instructions for U...

Page 5: ...anager Notification Highlights an area which requires attention Caution Highlights an error or precautionary statement which requires attention Refer to safety related warnings and precaution notes in...

Page 6: ...Health Record HCP Health Care Professional ID Identification QC Quality Control RFID Radio Frequency Identification UK United Kingdom USB Universal Serial Bus WHO World Health Organization HIS Hospita...

Page 7: ...nly use auto disabling single use lancing devices Dispose of all Test Strips used for patient or Quality Control testing safely in accordance with local regulations and procedures The LumiraDx Instrum...

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Page 9: ...g test results on the touch screen Single or multiple Instruments can be connected to the LumiraDx Connect Manager for extended functionality and configuration LumiraDx EHR Connect can enable the tran...

Page 10: ...k 2 4 User ID 2 5 Operating mode and first time setup 2 6 The LumiraDx Instrument 2 7 Power supply 2 8 LumiraDx Lot Calibration File installation 2 9 Extended functionality and operating modes 3 Prepa...

Page 11: ...ting 6 Software Updates 7 Troubleshooting 8 Maintenance and Disposal 9 Instrument Specifications 10 Ancillary Devices 10 1 LumiraDx Barcode Scanner 10 2 LumiraDx USB Memory Stick 10 3 LumiraDx Connect...

Page 12: ...Service Refer to the Customer Service chapter of this Platform User Manual for contact information Please note Instructions are combined with example screenshots Some screens may look different on the...

Page 13: ...fety information at the start of this Platform User Manual before operating the Instrument In addition please watch the LumiraDx Platform Training Video available at www lumiradx com 1 3 Summary of th...

Page 14: ...ot Calibration File is installed by placing the RFID tag in the Test Strip Carton against the RFID reader in the Instrument Quality assurance The LumiraDx Instrument ensures the quality of test result...

Page 15: ...Instrument at a temperature between 15 C and 30 C 59 F and 86 F and at a relative humidity between 10 and 90 non condensing Specific test operating conditions may be more restrictive Always place the...

Page 16: ...ing a patient test Place the Instrument on a level stable surface before starting a test Do NOT use any substance other than the sample types indicated in the LumiraDx Test Strip Product Insert on the...

Page 17: ...and procedures Follow the test operating conditions in the LumiraDx Test Strip Product Insert Follow the information on correct handling of Test Strips in the LumiraDx Test Strip Product Insert Clean...

Page 18: ...y unit that is provided with the Instrument Use the appropriate power blade for the region The correct power supply unit and adapter is required to maintain the safety and electromagnetic compatibilit...

Page 19: ...ear on the screen refer to the Troubleshooting chapter in this Platform User Manual For questions not answered in the LumiraDx User Manuals or Product Inserts please contact Customer Service Refer to...

Page 20: ...ed Place the Instrument on a level stable surface Power on by briefly pressing the power button at the rear of the Instrument Enter User ID and or password to login The Instrument touch screen will di...

Page 21: ...s to Instrument settings including language time and date 2 5 Operating mode and first time setup The language and current date and time will need to be set by the administrator prior to performing a...

Page 22: ...ion with the LumiraDx family of Test Strips for the in vitro quantification of various analytes in a range of biological samples whole blood plasma serum urine 2 6 The LumiraDx Instrument Test Strip s...

Page 23: ...operation the Instrument touch screen always displays the battery power level and provides an alert when the battery level is low To save power when battery operated the Instrument will automatically...

Page 24: ...nstallation is performed manually Locate the RFID reader by looking for the symbol on the side of the Instrument To install a new Lot Calibration File touch the back of the Test Strip Carton to the sy...

Page 25: ...als Manage compliance and governance functions LumiraDx Connect Manager LumiraDx Connect Manager Electronic Health Record LumiraDx Instrument LumiraDx Connect Hub or LumiraDx Connect App LumiraDx Inst...

Page 26: ...n pair of gloves should be worn before testing each patient Only use auto disabling single use lancing devices 3 2 Inserting and removing Test Strips Hold the Test Strip by gripping the blue label end...

Page 27: ...b Line up black line on Test Strip with black line on Instrument Test type Sample Application Area Apply sample or Quality Control solution AFTER inserting Test Strip Preparation for Testing 25 Note T...

Page 28: ...llowing techniques can be used until the fingertip has increased colour Ask the patient to rinse their hands with warm water Ask the patient to hold his or her arm straight down at their side Massage...

Page 29: ...o the finger Sample collection advice Use a lancet on the selected finger and produce a blood droplet on the end of the finger Hold the transfer tube horizontally and touch the tip to the blood sample...

Page 30: ...trip When the sample is detected the Instrument will sound and a confirmation message will be displayed The Instrument display will prompt to close the door Dispose of the lancet in the appropriate cl...

Page 31: ...Dispose of the transfer tube safely in accordance with local regulations and procedures 3 5 Sample application using other sample types Refer to LumiraDx Test Strip Product Inserts for information on...

Page 32: ...time setup set preferences perform patient and Quality Control tests and view result history Extended functionality for Connected Instruments is also described Please note Instructions are combined wi...

Page 33: ...s Administrator settings menu The administrator can set date and time Refer to the Instrument Operation chapter in this Platform User Manual for instructions The About screen provides information on I...

Page 34: ...ne operation are provided on a tear out sheet in the Platform Quick Reference Guide 1 Power on Power on the Instrument by pressing the power button at the rear of the Instrument or tap the touch scree...

Page 35: ...ter Tap Done then check the date and time are correct and tap Confirm to save Return to the home screen and tap Logout 3 Set language The language is set to English by default To set a different langu...

Page 36: ...nsure the Instrument is within range of a LumiraDx Connect Hub or a device running the LumiraDx Connect App within approximately 10 meters If appears at the top of the screen the Instrument is connect...

Page 37: ...or to set the volume using the slider Tap Done to save and return to the Settings menu All users can set display and sound preferences in the Settings menu Display In the Display menu the brightness o...

Page 38: ...tion during a patient test or on the test result screen tap the at the top of the touch screen To cancel a patient test tap Cancel at the top of the touch screen and follow the Instrument prompts ALWA...

Page 39: ...to display the keyboard Enter password and tap Login to complete the login If using a Connected Instrument tap the User ID field to use the keyboard to enter User ID Alternatively scan User ID using...

Page 40: ...4 Enter patient details Tap any field to use the keyboard to enter patient details or scan the patient ID using the Barcode Scanner Refer to the Ancillary devices chapter in this Platform User Manual...

Page 41: ...Strip from its packaging and hold with the blue label side facing upward Line up the black alignment rib on the Test Strip with the black line on the Instrument Insert the Test Strip gently as far as...

Page 42: ...te The Instrument will prompt to install the Lot Calibration File when inserting a new Test Strip Lot Note Capillary Blood refers to both finger stick and transfer tube applications 8 Confirm test and...

Page 43: ...sample by capillary action Note Pay attention to the countdown for sample application to avoid test errors This will be displayed as a countdown bar and the Instrument will sound with 10 seconds rema...

Page 44: ...f the door is not closed by the end of the countdown the Instrument will sound and display an error message 11 Test processing The test will start and a progress bar will be displayed whilst the test...

Page 45: ...a test result is rejected Once the desired comment s are entered tap Done to return the result screen Tap Finish to save the test result to Result History and complete the test 13 Remove and dispose...

Page 46: ...LumiraDx Quality Controls Preparing for a QC test requires the same steps as preparing to perform a patient test The only difference in the test method is the use of Quality Control solutions instead...

Page 47: ...fore performing a QC test Place the Instrument on a level stable surface before starting a test Use only LumiraDx Quality Control solutions Apply Quality Control solution AFTER inserting the Test Stri...

Page 48: ...fer to First time setup in this chapter for more information 3 Prepare Quality Control solution Prepare the Quality Control solution according to the LumiraDx Quality Control Pack Insert 4 Tap Quality...

Page 49: ...on the Instrument Insert the Test Strip gently as far as it will go The Instrument will sound when the Test Strip is detected 7 Confirm test type Check the test type is correct and tap Confirm to pro...

Page 50: ...st Strip draws up the Quality Control solution by capillary action Note Pay attention to the countdown for solution application to avoid test errors This will be displayed as a countdown bar If the so...

Page 51: ...s This will be displayed as a countdown bar If the door is not closed by the end of the countdown the Instrument will sound and display an error message 10 QC test processing The QC test will start an...

Page 52: ...ory and complete the test 12 Remove and dispose of Test Strip The Instrument will prompt to remove the Test Strip Gently pull the blue label end of the Test Strip to remove and dispose Disinfect the I...

Page 53: ...QC levels may be required depending on test type Refer to the LumiraDx Quality Control Pack Insert for more information on QC levels Repeat steps in Performing a Quality Control test to test any addi...

Page 54: ...results tap Result History 3 Review test results All entries are shown in date order with the newest at the top Test results can be filtered by selecting Patient Tests QC Tests Rejected Tests or Inva...

Page 55: ...Instrument Operation 53...

Page 56: ...enever it is visibly dirty The Instrument should be disinfected after each patient use or anytime you believe the Instrument maybe contaminated with a patient sample or Quality Control solution What s...

Page 57: ...for 5 minutes Let air dry Dispose of the wipes in accordance with local procedures The Instrument is now ready to perform another test For technical assistance or questions information about the TECc...

Page 58: ...uired to complete the software update 6 Software Updates 2 Power on Power on the Instrument by pressing the power button at the rear of the Instrument A progress bar on the Instrument display will ind...

Page 59: ...he Instrument status or error and an instruction Error messages contain an identifying code that may be used for further troubleshooting purposes Follow the instruction to resolve the issue If the iss...

Page 60: ...r supply unit before the battery runs out Example error message Description and instruction Tap OK to proceed and follow the suggested instruction s to resolve the issue In this example remove and dis...

Page 61: ...tions on how to install the Lot Calibration File 2 Ensure that the back of the Test Strip Carton is touching the symbol on the side of the Instrument continually until the Instrument sounds and a conf...

Page 62: ...o the First time setup section of this Platform User Manual for instructions on setting date and time Patient test result is red If the patient test result is displayed in red Test results that are ab...

Page 63: ...nance and has no serviceable parts No attempt should be made to open the Instrument In case of Instrument failure or damage or to arrange collection disposal contact LumiraDx Customer services on 0080...

Page 64: ...storage 1000 test results with date time and comments Lot calibration files Communications 2 x USB ports RFID Reader 13 56MHz 0 dBi EIRP Bluetooth Low Energy 2 4GHz ISM band 2400MHz to 2483 5 MHz 0 5d...

Page 65: ...Scanner can be used to scan User ID for login Note The same User ID must be assigned to the user in Connect Manager 10 Ancillary Devices Ancillary Devices 63 Scanning distance Hold scanner approximat...

Page 66: ...64 Ancillary Devices LumiraDx Barcode Scanner Cradle Attaching LumiraDx Barcode Scanner cradle to Instrument Note Correct orientation of Barcode Scanner cradle...

Page 67: ...es 65 10 2 LumiraDx USB Memory Stick LumiraDx Desktop Stand LumiraDx USB Memory Stick used for Instrument software updates Note Right side USB port nearest the power button at the rear of the Instrume...

Page 68: ...6 Ancillary Devices 10 4 LumiraDx Connect App Refer to LumiraDx Connect User Manual and Connect Hub Pack Insert for information and setup instructions Refer to LumiraDx Connect User Manual for informa...

Page 69: ...tion LumiraDx disclaims any and all warranties express or implied including but not limited to any warranty of merchantability fitness for a particular purpose and non infringement regarding the produ...

Page 70: ...e healthcare facility level http www who int gpsc ipc components guidelines en 3 CDC Guideline for Isolation Precautions Preventing Transmission of infectious Agents in Healthcare Settings 2007 https...

Page 71: ...e product is sold Please refer to www lumiradx com for further information 13 2 Compliance LumiraDx UK Ltd hereby declares that the product complies with all relevant European Directives and Regulatio...

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Page 76: ...erved worldwide For product and connectivity support please contact LumiraDx customer services on 00800 5864 7239 or by email customerservices lumiradx com The customer international free phone number...

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